Staff Regulatory Affairs Associate

Responsibilities

• Develop and drive regulatory strategies for Software as a Medical Device (SaMD), AI/ML-enabled products, wearable technologies, and other digital health solutions
• Serve as the primary regulatory advisor to cross functional teams, providing guidance throughout concept development, feature design, model development, and validation
• Partner with Product, Engineering, and AI/ML teams to evaluate regulatory implications of new features, algorithms, health insights, claims, intended uses, and user experiences, and recommend appropriate regulatory and claims strategies
• Develop regulatory approaches for emerging technologies, such as foundation models, generative AI, and adaptive algorithms, where regulatory expectations are evolving and established pathways may not exist
• Serve as an internal subject matter expert on FDA digital health policies, SaMD frameworks, AI/ML regulatory approaches, international regulations, and emerging industry trends
• Support regulatory interactions with FDA reviewers, notified bodies, and other authorities to discuss innovative technologies, regulatory pathways, and product development strategies
• Provide strategic leadership and input for FDA and EU submissions, including Q-Submissions, 510(k)s, De Novo requests, EU MDR technical documentation
• Monitor and interpret evolving requirements, guidance documents, and standards related to digital health, AI/ML technologies, software lifecycle processes, Predetermined Change Control Plans (PCCPs), and emerging technologies
• Communicate regulatory risks, opportunities, and strategic considerations to stakeholders and leadership to support informed product and development decisions
• Collaborate cross-functionally to develop scalable regulatory approaches that enable innovation while maintaining compliance and product quality

Qualifications

• Bachelor’s degree in Regulatory Affairs, Engineering, Computer Science, or a related field. Advanced degree preferred
• 8+ years of Regulatory Affairs experience within the medical device industry
• Demonstrated experience developing regulatory strategies for Software as a Medical Device (SaMD), digital health products, wearable technologies, or AI/ML-enabled medical technologies
• Strong understanding of FDA medical device regulations, regulatory pathways, and submission processes, including experience supporting or leading Q-Submissions, 510(k)s, De Novo submissions, or related regulatory interactions
• Working knowledge of international medical device regulations, particularly FDA and EU MDR frameworks
• Familiarity with AI/ML technologies, machine learning lifecycle concepts, foundation models, generative AI, and emerging regulatory approaches to artificial intelligence in healthcare
• Demonstrated experience partnering directly with software engineering, product management, data science, or AI/ML teams to shape product development and regulatory strategy
• Strong understanding of intended use, claims strategy, risk classification, software functionality, software lifecycles, and clinical evidence considerations
• Ability to translate complex regulatory requirements into practical guidance for product, engineering, and business stakeholders
• Demonstrated success influencing cross-functional teams and operating effectively in fast-paced, highly innovative environments
• Strong written and verbal communication skills, with the ability to clearly articulate regulatory strategy and recommendations to both technical and non-technical audiences